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CTRI Number  CTRI/2026/01/101080 [Registered on: 14/01/2026] Trial Registered Prospectively
Last Modified On: 14/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Occlusal Contact Changes After Fixed Braces and Clear Aligners in Class I Malocclusion: A T-Scan-Based Prospective Study 
Scientific Title of Study   A Comparative Analysis of Occlusal Parameters in Class I Malocclusion cases treated with Fixed Mechanotherapy and Clear Aligners using T-Scan : A Prospective Study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anand Badavannavar 
Designation  Professor 
Affiliation  KLEVK Institute of Dental  
Address  Department of Orthodontics, KLEVK Institute of Dental sciences Nehru Nagar Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9845857686  
Fax    
Email  anand_ortho@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Anand Badavannavar 
Designation  Professor 
Affiliation  KLEVK Institute of Dental  
Address  Department of Orthodontics, KLEVK Institute of Dental sciences Nehru Nagar Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9845857686  
Fax    
Email  anand_ortho@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Anand Badavannavar 
Designation  Professor 
Affiliation  KLEVK Institute of Dental  
Address  Department of Orthodontics, KLEVK Institute of Dental sciences Nehru Nagar Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9845857686  
Fax    
Email  anand_ortho@yahoo.co.in  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Dr Anand Badavannavar 
Address  KLEVK Institute of Dental sciences 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anand Badavannavar  KLE VK Institute of Dental sciences  room no 8 Dept of orthodontics
Belgaum
KARNATAKA 		 9845857686

anand_ortho@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KAHER ethical commitee(human)for PhD research Belagavi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  orthodontic class 1 malocclusion cases 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  fixed orthodontics  MBT mechanics 
Intervention  T scan  T Scan system 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Patients in the age group of 18-40 years.
Orthodontic treatment with either fixed mechanotherapy or clear aligners.
Skeletal Class I malocclusion(ANB angle 0-4°).
Mild to moderate crowding (less or equalto6mm).
Fully erupted permanent dentition.
No active periodontal disease or severe TMD.  
 
ExclusionCriteria 
Details  Patients with missing teeth (excluding 3rd molars), dental implants, fixed prosthesis.
Patients who have undergone orthodontic treatment.
Patients with Cleft Lip and Palate and congenital syndromes.
Patients with systemic diseases.
Patients with compromised periodontal oral health.
Class II or III malocclusion.
History of bruxism, or severe parafunctional habits
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Quantitative assessment and comparison of occlusal force distribution and occlusal contact timing in Class I malocclusion patients treated with fixed mechanotherapy versus clear aligners, as recorded using the T-Scan computerized occlusal analysis system.  Time Points of Assessment of Outcomes
Baseline (T0): Before initiation of orthodontic treatment

Post-treatment (T1): Immediately after completion of orthodontic treatment malocclusion patients treated with fixed mechanotherapy versus clear aligners, as recorded using the T-Scan computerized occlusal analysis system. 
 
Secondary Outcome  
Outcome  TimePoints 
secondary outcomes can include:

Occlusal timing parameters (time to first contact, occlusion time, disclusion time) & left–right force asymmetry changes from T0 to T1.

Number & location of occlusal contacts (anterior vs posterior) & force distribution per quadrant, comparing fixed mechanotherapy & clear aligners 		 Baseline Before initiation of orthodontic treatment
Posttreatment Immediately after completion of orthodontic treatment & appliance removal final aligner stage.
if permittedT2 3 months after debonding or delivery of retainers to assess short-term occlusal stability. 
Nil  Nil 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [anand_ortho@kledental-bgm.edu.in].

  6. For how long will this data be available start date provided 12-01-2026 and end date provided 12-01-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   This prospective study aims to compare occlusal parameters in Class I malocclusion patients treated with fixed mechanotherapy and clear aligners using the T Scan computerized occlusal analysis system. The study evaluates occlusal force distribution occlusal contact timing and center of force before and after orthodontic treatment. Patients are assessed at baseline and after completion of treatment to determine the efficiency and balance of occlusion achieved by the two treatment modalities. The findings are expected to provide objective evidence on occlusal outcomes and stability associated with fixed appliances and clear aligner therapy and help clinicians make informed treatment decisions based on functional occlusal performance rather than visual assessment alone. 
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